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Executive Director - Market Quality

Req ID:  3236

Working Location: Nationwide 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Executive Director, Market Quality is responsible for establishing and maintaining a complaint handling system which is compliant to US FDA regulations for complaint handling (21 CFR 820.198),MDR reporting (21 CFR 803.3), ISO 13485:2016 (EMEA), Canadian & Brazilian vigilance reporting In addition, this position will be responsible for maintaining compliance to OCI & LATAM requirements.

 

The Executive Director, Market Quality shall have direct leadership, accountability and oversight of a Post Market Surveillance system for assessing and reporting to regulatory authorities for all data sources on OSTA products: adverse events (AEs), complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, compliance related communications from regulatory agencies and changes to relevant domestic and international standards and/or regulations for all OSTA sites and businesses

Job Duties

* Responsible and accountable for global Medical Device Reporting. Including management and execution of OSTA PMS procedures, local work instructions, practices and compliance of complaint and reporting performance, working in a cross-functional team with other OSTA management/departments.

 

* Responsible for cross functional teams (Medical Safety, Field Safety, Manufacturing, and R&D) that evaluate product risk and potential safety issues. The teams will assess deaths, serious injuries, and malfunctions in support of regulatory agency product surveillance requirements and ensure the timely initiation and completion of HHEs and regulatory filings if applicable.

 

* The incumbent will hire, develop, and organize a department of engineers, technicians, medical professionals, including managers, such that the team meets all requirements in an efficient, process, results oriented manner.

 

* The Executive Director will work closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations is performance and documented in HHEs and safety evaluations of products.

 

* Responsible for working in partnership with Design Quality Assurance in resolving customer issues and developing continuous process improvement initiatives. Work with OSTA management and Design QA to ensure field performance and safety issues are properly addressed for new product requirements and/or risk management files.

 

* This individual will develop and implement programs to review literature and internet for potential complaints and AE/MDRs.

 

* Serves as a Core leadership team member reporting directly to the VP, Market Quality.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor of Science, medical, engineering, or scientific discipline.

 

* Minimum of 10 years management level experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations ( QSR ) compliance and quality assurance.

 

* Demonstrated experience in developing and leading a top performing Quality team is required,

 

* Other Considerations (travel/hours availability, etc.): Up to 75% domestic travel, if not co-located with an Olympus manufacturing and/or service center.

 

PREFERRED QUALIFICATIONS

* Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses. 

 

*  Proficient understanding of medical device regulations both domestic and international with specific expertise in Complaint Handling, Adverse Event Reporting, Field Actions/Recalls, Regulator Inspections, product performance trending, risk management, and Corrective and Preventive Actions (CAPA).

 

* Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || California (US-CA) || San Jose || 


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